Purpose

The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)

Conditions

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men or women ≥ 50 years old, capable of giving signed informed consent - Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE) - Total area of CNV (including both classic and occult components) > 50% of the total lesion area in the SE - The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE - Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol: - Total lesion size > 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye - Scar, fibrosis, or atrophy involving the central subfield in the study eye - Scar or fibrosis involving > 50% of the total lesion in the study eye - Presence of retinal pigment epithelium tears or rips involving the macula in the study eye - History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study - Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study - Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye - History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye - Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization - Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening - Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins - History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation - Other protocol-specified exclusion criteria

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ABP 938 8 mg
Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
  • Drug: ABP 938 8 mg
    IVT injection
Active Comparator
Aflibercept (US) 8 mg
Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
  • Drug: Aflibercept (US) 8 mg
    IVT injection
    Other names:
    • EYLEA HD

Recruiting Locations

South Coast Retina Center - RCA
Long Beach, California 90607

California Eye Specialists Medical Group, Inc
Pasadena, California 91107

Retina Consultants of San Diego
Poway, California 92064

Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)
Sacramento, California 95825

Retina Group of Florida
Fort Lauderdale, Florida 33308

Medeye Associates - Research
Miami, Florida 33143

Advanced Research, LLC
Pensacola, Florida 32503

Retina Associates
Elmhurst, Illinois 60126

Retina Consultants of Minnesota
Edina, Minnesota 55435

Mississippi Retina Assoc
Madison, Mississippi 39110

Charleston Neuroscience Institute
Charleston, South Carolina 29414-5896

Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)
Ladson, South Carolina 29456

Palmetto Retina Center, Florence (RCA)
West Columbia, South Carolina 29169

Texas Retina Associates (TRA) - Arlington
Arlington, Texas 76012

Texas Retina Associates (TRA) - Dallas Main
Dallas, Texas 75231

Texas Retina Associates - Fort Worth
Fort Worth, Texas 76104

Retina Consultants of Texas - Schertz
Schertz, Texas 78154

Vitreoretinal Associates of Washington
Bellevue, Washington 98004-3779

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.